A Special-Limited Community Permit shall be obtained by a Class II or Class III Institutional Pharmacy that dispenses medicinal drugs, including controlled substances to:

1. (1) Employees, medical staff and their dependents for their personal use;
2. (2) Patients of the hospital who are under a continuation of a course of therapy not to exceed a three (3) day supply;
3. (3) Patients obtaining medical services in the facility’s emergency room and, whenever it is otherwise appropriate, as indicated in the applicant’s policy and procedure manual; and,

4. (4) Discharged patients of the hospital who are under a continuation of a course of therapy using multi-dose medicinal drugs if the following requirements are met:

   1. (a) The label affixed to a container used in dispensing multi-dose medicinal drugs contains at least the following information:

      1. The name of and contact information of the pharmacy.

      2. The name of the prescriber.

      3. The name of the patient.

      4. The date of the original filling and any applicable expiration date.

      5. The prescription number or other prescription identification adequate to readily identify the prescription.

      6. The directions for use.

      7. The name, strength, and size of the medicinal drug dispensed; and,

      8. The quantity of the drug in the container.

   2. (b) The patient is deemed competent to handle and administer the multi-dose medicinal drug.
   3. (c) A specific order is written by the patient’s physician to authorize that the multi-dose medicinal drug is appropriate to dispense upon discharge.

   4. (d) Before the hospital dispenses a multi-dose medicinal drug as specified in subsection (4) of this rule, the hospital shall establish protocols to ensure the following:

      1. Infection control during transport and handling of multi-dose medicinal drug containers that have been in contact with a patient.

      2. Patient or caregiver education on administration of the multi-dose medicinal drug if necessary on an individual basis.

   5. (e) A “multi-dose medicinal drug” as used in this rule means, but is not limited to, commercially available multi-dose packages such as inhalers, ocular products, insulin vials or pens, otic products, bulk antibiotic suspensions, topical agents, and methylprednisolone dose packets dispensed to inpatients, provided in containers that may exceed a three (3) day supply, and are intended to be continued by the patient on an outpatient basis but not to be re-filled by the hospital. Controlled substances are not considered multi-dose medicinal drugs as defined in this rule.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 7-31-91, Formerly 21S-28.810, 61F10-28.810, 59X-28.810, Amended 7-17-05, 2-10-14, 9-27-18.